BEUDAMED
    FDA Adverse Event Other Summary report: N

    LENSAR LASER SYSTEM -FS 3D

    MDR report key: 4392285 · Received December 5, 2014

    Report

    Report Number
    3009026057-2014-00037
    Event Type
    Other
    Date Received
    December 5, 2014
    Date of Event
    November 11, 2014
    Report Date
    December 5, 2014
    Manufacturer
    LENSAR INC
    Product Code
    OOE
    PMA / PMN Number
    K120214
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A LENSAR CLINICAL APPLICATION SPECIALIST REPORTED THAT WHILE ON SITE FOR CLINICAL TRAINING, THE DOCTOR HAD AN ANTERIOR RHEXIS EXTENSION IN THE LAST PATIENT OF THE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788441 LENSAR LASER SYSTEM -FS 3D LENSAR LASER SYSTEM -FS 3D OOE LENSAR INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other